Tyvaso Institutional Start Kit

This medication is used to treat a type of high blood pressure in the lungs (pulmonary arterial hypertension). Treprostinil helps to increase your ability to exercise and improves symptoms such as shortness of breath and tiredness. It works by relaxing and widening the blood vessels (arteries) in the lungs and other parts of the body so that blood can flow more easily. This medication belongs to a class of drugs known as vasodilators.

Read the Patient Information leaflet available from your pharmacist. This medication comes in a plastic container called an ampule. Follow the manufacturer's instructions on how to prepare each dose. This product is used with a special breathing device (nebulizer). Consult your doctor, pharmacist or respiratory therapist on how to inhale this medication properly with this equipment. Make sure you understand how to properly clean the nebulizer to prevent infections. If you have any questions, consult your health care professional.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Do not mix with other inhaled medications in the nebulizer.

Inhale this medication by mouth as directed by your doctor, usually 4 times daily during waking hours, at least 4 hours apart. Do not drink the solution. Do not get this medication on the skin or in your eye. If this happens, rinse the area with water. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

To avoid missing doses, be sure to have a back-up nebulizer in case your regular device stops working properly.

Tell your doctor if your condition does not improve or if it worsens.

Cough, headache, throat irritation, nausea, flushing, dizziness, or jaw/muscle/bone pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Fainting is another common side effect. If fainting does occur, get medical help right away.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: unusual bleeding/bruising.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using treprostinil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, kidney problems, liver problems, bleeding problems, other breathing problems (such as asthma).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Once the foil pack is opened, the ampules should be used within 7 days. After an ampule has been opened, discard any unused solution at the end of the day. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Treprostinil may lower your blood pressure. Your doctor may also direct you to take other medications that may also lower your blood pressure (such as "water pills"/diuretics such as furosemide, ACE inhibitors such as captopril, calcium channel blockers such as nifedipine, other vasodilators such as nitrates). Your doctor may also prescribe "blood thinners" (such as warfarin) to prevent blood clots. Treprostinil may increase your risk of bleeding if you take "blood thinners." Your doctor or pharmacist will monitor you for these possible drug interactions. Tell your doctor or pharmacist right away if you develop symptoms such as easy or unusual bleeding/bruising, severe dizziness, or fainting.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Laboratory and/or medical tests (such as blood pressure) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.